Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Device: Portable ultrasound machine

• Registration Number: NCT00996905
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals.

The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.

Detailed Description

Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.

This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• ability to Speak in English
• requesting epidural analgesia for labour
• having easily palpable spine (clinically 'easy' back)

Exclusion Criteria

• contraindications to epidural analgesia
• patients with a history of difficult epidural insertions or spinal anesthetic
• Patients with a known history of back surgery
• patients with known significant kyph0scoliosis

For Anesthesiologists:

Inclusion Criteria:

• Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beginner Ultrasound (BU)	Portable ultrasound machine	Beginner level (residents) doing epidural insertions with the help of ultrasound scanning.
Experienced Ultrasound	Portable ultrasound machine	Experienced level (fellows) doing epidural insertions with the help of ultrasound scanning.

Primary Outcome Measures

Name	Time	Method
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.	20 minutes

Secondary Outcome Measures

Name	Time	Method
The occurrence of inadvertent dural punctures.	24-48 hours
Number of attempts to thread the epidural catheter	20 minutes
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)	2 hours
The need of the anesthesiologist to call for assistance with the procedure	30 minutes
Patient satisfaction as determine by a questionnaire	24 hours and 1 week

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada